A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

November 11, 2024 updated by: Kwang Dong Pharmaceutical co., ltd.
The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Soo Woong Kim, Dr
  • Phone Number: 02-2072-2426
  • Email: swkim@snu.ac.kr

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

[Main Inclusion Criteria]

  • Has met diagnostic criteria for HSDD for at least 6 months
  • Is willing and able to understand and comply with all study requirements
  • Has a normal pelvic examination at screening

[Main Exclusion Criteria]

  • Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
  • Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bremelanotide
Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period
Drug: Bremelanotide
Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.
Placebo Comparator: Placebo
Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period
Drug: Placebo
Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline to End of Study in the desire domain from the FSFI
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline to End of Study in FSDS-DAO (Item 13)
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in the FSDS-DAO Total Score
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the total FSFI score based on the 19 questions
Time Frame: Baseline up to End of Study(8weeks)
The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.
Baseline up to End of Study(8weeks)
Change in mean Level of Sexual Arousal from FSEP-R Q6
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the scored time spent being concerned by difficulty with sexual arousal as measured by the FSDS-DAO Q14.
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the total number of SSEs.
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5)
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from baseline in the score for feeling bothered by low sexual desire as measured by the FSDS -DAO Q13 using all available double-blind data(visit 4, 5)
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)
Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.
Time Frame: Baseline up to End of Study(8weeks)
Baseline up to End of Study(8weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kwang Dong Pharmaceutical co., ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soo Woong Kim, Dr, Seoul National University Hospital
  • Principal Investigator: Tak Kim, Dr, Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KD-BMT-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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